MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number ASD48A

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

A4: patient weight is not available.Per the gore® cardioform asd occluder instruction for use, in the section ¿potential device ¿ or procedure-related adverse events¿.Adverse events associated with the use of the occluder may include, but are not limited to: device embolism.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.

Event Description

It was reported the physician implanted a 48mm gore® cardioform asd occluder to close an atrial septal defect.Later that evening the device embolized.The next day, the device was removed in an additional transcatheter procedure, and the defect was closed surgically.The patient was doing well post surgery.

Manufacturer Narrative

Added codes to section h6.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17238659
• MDR Text Key: 318290415
• Report Number: 2017233-2023-04075
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636525
• UDI-Public: 00733132636525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD48A
• Device Catalogue Number: ASD48A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female